ChiCTR2300078592 版本V1.0 版本创建时间2023/12/13 10:50:47 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2300078592 

最近更新日期：

Date of Last Refreshed on：

 2023-12-13 10:50:22 

注册时间：

Date of Registration：

 2023-12-13 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于认知功能的伞式精准化干预计划对COPD患者自我管理行为的影响：一项随机对照研究

Public title：

Effect of targeted intervention plan based on cognitive function on self-management behavior in COPD patients: An Umbrella Randomized Study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于认知功能的COPD患者自我管理伞式精准化干预方案的构建和实证研究

Scientific title：

Construction and empirical study of umbrella-type precise intervention scheme for COPD patients' self-management based on cognitive function

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

陈晓梅 

研究负责人：

陈晓梅 

Applicant：

Xiaomei Chen 

Study leader：

Xiaomei Chen 

申请注册联系人电话：

Applicant telephone：

 +86 177 6140 8093

研究负责人电话：

Study leader's
telephone：

+86 177 6140 8093

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 Chenxm19890121@163.com

研究负责人电子邮件：

Study leader's E-mail：

 Chenxm19890121@163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

重庆市沙坪坝区高滩岩正街30号

研究负责人通讯地址：

重庆市沙坪坝区高滩岩正街30号

Applicant address：

30 Gaotanyan Street, Shapingba District, Chongqing,China

Study leader's address：

30 Gaotanyan Street, Shapingba District, Chongqing,China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

陆军军医大学护理系 邛崃市医疗中心医院

Applicant's institution：

School of Nursing, Army Medical University Medical center hospital of Qionglai

研究负责人所在单位：

陆军军医大学护理系 邛崃市医疗中心医院

Affiliation of the Leader：

School of Nursing, Army Medical University Medical center hospital of Qionglai

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 伦审(研)第(2023)56号

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

邛崃市医疗中心医院伦理审查委员会

Name of the ethic committee：

Ethics examination Committee of medical center hospital of Qionglai

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-11-13 00:00:00

伦理委员会联系人：

宋慧琴

Contact Name of the ethic committee：

Huiqin Song

伦理委员会联系地址：

邛崃市临邛镇杏林路172号

Contact Address of the ethic committee：

No.172 Xinglin Road, Linqiong Town, Qionglai City

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 1338966335

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 Songhuiqin1971@163.com

研究实施负责（组长）单位：

邛崃市医疗中心医院

Primary sponsor：

medical center hospital of Qionglai

研究实施负责（组长）单位地址：

成都邛崃市杏林路172号

Primary sponsor's address：

No.172 Xinglin Road, Linqiong Town, Qionglai City

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

四川

市(区县)：

成都

Country：

China

Province：

Sichuan

City：

Chengdu

单位(医院)：

邛崃市医疗中心医院

具体地址：

邛崃市临邛镇杏林路172号

Institution
hospital：

medical center hospital of Qionglai

Address：

No.172 Xinglin Road, Linqiong Town, Qionglai City

经费或物资来源：

国家社会科学基金

Source(s) of funding：

National Social Science Funding Project

研究疾病：

慢性阻塞性肺疾病  

Target disease：

Chronic obstructive pulmonary disease

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

以认知功能和患者激活为分类靶点，聚类分析为抓手，建立COPD患者亚群，并以亚群患者为主体、可改变的风险预测因素与认知功能为基石、质性研究为途径，探讨不同类型特征患者的自我管理需求。再结合上述研究成果设计构建适合不同亚群患者个性化特征的伞式精准化自我管理干预方案，并通过随机对照实验评价方案效果。  

Objectives of Study：

Taking cognitive function and patient activation as classification objectives, and cluster analysis as the starting point, we set up subgroups of COPD patients, taking the subgroups as the main body, taking variable risk predictors and cognitive function as the cornerstone, and taking qualitative research as the way to explore the self-management needs of patients with different types of characteristics.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

（1）存在自我管理行为障碍的COPD亚群患者，且处于稳定期 （2）年龄40-80岁 （3）意识清楚且有良好的理解及沟通能力 （4）自愿参与本研究者

Inclusion criteria

(1) COPD subgroup patients with self-management behavior disorder, and in a stable period. (2) 40-80 years old (3) clear consciousness and good understanding and communication skills. (4) Voluntary participation in this research.

排除标准：

（1）痴呆患者 （2）严重心功能障碍、肺结核活动期者 （3）最近6个月有参与其他相关研究者

Exclusion criteria：

(1) Patients with dementia (2) those with severe cardiac dysfunction and active pulmonary tuberculosis. (3) Have participated in other related researchers in the last 6 months.

研究实施时间：

Study execute time：

从 From 2023-12-15 00:00:00至 To 2024-03-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-12-16 00:00:00 至 To 2023-12-30 00:00:00

干预措施：

Interventions：

组别：

干预组

样本量：

 36

Group：

Intervention group

Sample size：

干预措施：

实施内容: 包含两个通用方案（所有参与者）和三个靶向方案（针对不同认知和激活程度的参与者）。 健康知识指导（通用方案1） ①实施对象：所有纳入干预组的参与者 ②实施周期及频率：从入组后第一周开始实施，之后每周一次(按宣教主题依次进行），每次约30-50分钟，共5次。 ③实施形式及地点：在医院借助多媒体设备进行团体面对面宣讲、护士现场演示并解说、以腾讯会议形式进行线上宣讲、患者居家随访 ④宣教主题：每周一个宣教主题，分别为COPD相关专业知识、运动训练管理、呼吸肌训练管理、吸入剂管理、氧疗管理。 ⑤宣教原则：根据参与者的整体认知功能分组（低认知/低激活、低认知/高激活患者一组，正常认知/低激活患者一组），两组分开宣讲。低认知组宣讲内容较为简单、注重细节、宣讲时间稍长。 有氧运动训练（通用方案2） ①实施对象：所有纳入干预组的参与者 ②实施时间：从入组后第二周开始实施，共11周。每周至少4次，每次30-50分钟 ③训练方式：结合患者病情，推荐患者选择有氧步行运动或太极拳，患者也可根据自身喜好选择抗阻运动。随后根据个人能力水平逐渐增加频率、强度、持续时间 ④运动训练注意事项：建议患者在安全、熟悉的环境下进行活动，如平整的道路、适宜的照明、适宜的温度等；锻炼时着适合运动的服装和鞋袜；运动前有热身准备活动，逐渐增加用力，运动后做好放松活动 ⑤使用华为运动手环监测患者的运动心率，运动心率为最大心率（220-实际年龄）的60%-80% ⑥干预督导：建议参与者每次运动后完成运动日志，内容包括：运动类型、运动起始时间、最高运动心率、运动不良事件、运动过程感受。参与者也可选择在每次运动后将以上信息发送给研究团队成员。 认知训练（靶向方案1） ①实施对象：参与者中存在整体认知功能障碍的患者，即MoCA评分低于26分者 ②实施时间：从入组后第一周开始实施，之后每周一次，每次约45分钟，共10次（干预周期为12周） ③实施形式：家中有联网计算机的患者可居家自行练习；无计算机设备的患者干预团队成员每周到患者家中进行一次居家训练 ④训练内容：根据患者干预前评估的认知结果，在线认知训练系统将自动化推荐适合患者的认知训练模块（如收获萝卜、归心似箭、举棋不定、精打细算等），患者根据系统推荐及指示逐一训练即可 ⑤干预督导：计算机化认知训练：研究团队成员每周五之前登录后台系统查看参与者完成训练情况，及时提醒未完成的参与者积极完成 知识、技能刺激训练（靶向方案2） ①实施对象：参与者中存在整体认知功能障碍的患者，即MoCA评分低于26分者 ②实施时间：从入组后第六周开始实施，之后每周一次（每次认知训练结束为，持续时间大约为10-15min） ③实施形式:居家随访、视频或电话督导 ④实施内容：根据回授法原理，让患者回答运动相关注意事项；现场显示吸入剂的使用方法；回答吸氧的注意事项等。 动机干预（靶向方案3） ①实施对象：参与者中激活度较低者，即PAM测试为level 1和 level 2者 ②实施时间：入组后第二周至第八周，每次15-20 min，每周1次，共9次（动机访谈）；入组第五周实施，每次30分钟以上，共一次（同伴教育）。 ③实施内容 设置动机访谈的时间表及主题：首次访谈时为参与者介绍动机访谈的安排及规则；随后每次访谈都设有相应的健康知识主题（依次为运动情况、呼吸肌锻炼情况、吸入剂使用情况、氧疗情况、日常健康生活管理情况、认知训练或认知刺激活动情况） 动机访谈要点：每次访谈时参与者需对他们健康行为的动机和信心评分（1-10分）；参与者需确定短期目标，以揭示这些目标与他们之前行为之间的矛盾；访谈最后总结要点，肯定参与者的可取行为，提出疑问之处，并要求参与者至少尝试一种提高自我效能和积极行为改变的策略 动机访谈原则：开放式问题，反思性回答；抵制纠正反射；理解和探讨患者自己的动机；共情倾听；授权患者、唤起希望和乐观精神 同伴教育：研究团队成员在激活度较高的患者选择2-3名参与者，通过线下或腾讯会议线上分享的形式讲述自身经验，并设有谈论环节，让患者之间充分交流，相互学习对方的优势之处 不同亚型COPD患者的实施方案：所有干预组的参与者都执行通用方案1和通用方案2；低认知/低激活的参与者同时执行靶向方案1、靶向方案2和靶向方案3；低认知/高激活的参与者只执行靶向方案1；正常认知/低激活的参与者只执行靶向方案2.

干预措施代码：

Intervention：

There are two general schemes (all participants) and three targeted schemes (for participants with different cognitive and activation levels). Health knowledge guidance (general scheme 1) ① Implementation target: all participants in the intervention group. ② Implementation cycle and frequency: it will be implemented from the first week after joining the group, and then once a week (according to the mission theme in turn), each time lasting about 30-50 minutes, a total of 5 times. ③ Implementation form and place: group face-to-face presentation in the hospital with the help of multimedia equipment, on-site demonstration and explanation by nurses, online presentation in the form of Tencent conference, and home follow-up of patients. ④ Mission theme: one mission theme per week, which is COPD related professional knowledge, exercise training management, respiratory muscle training management, inhalant management and oxygen therapy management. ⑤ Principle of propaganda and education: According to the overall cognitive function of the participants, the participants were divided into two groups (patients with low cognition/low activation, patients with low cognition/high activation and patients with normal cognition/low activation), and the two groups preached separately. The content of the low cognitive group is simple, attention to detail and a little longer. Aerobic exercise training (general scheme 2) ① Implementation target: all participants in the intervention group. ② Implementation time: it will be implemented from the second week after joining the group, with a total of 11 weeks. At least 4 times a week, 30-50 minutes each time. ③ Training mode: According to the patient's condition, patients are recommended to choose aerobic walking or Tai Ji Chuan, and patients can also choose resistance exercise according to their own preferences. Then gradually increase the frequency, intensity and duration according to the individual ability level. ④ Precautions for sports training: It is suggested that patients should carry out activities in a safe and familiar environment, such as smooth roads, suitable lighting and suitable temperature. Wear clothes, shoes and socks suitable for exercise; Have warm-up activities before exercise, gradually increase your strength, and do a good job of relaxation after exercise. ⑤ Use Huawei sports bracelet to monitor the exercise heart rate of patients, and the exercise heart rate is 60%-80% of the maximum heart rate (220- actual age). ⑥ Intervention and supervision: It is suggested that participants should complete an exercise log after each exercise, which includes: exercise type, exercise start time, maximum exercise heart rate, adverse sports events and exercise process feelings. Participants can also choose to send the above information to the research team members after each exercise. Cognitive Training (Targeting Scheme 1) ① Implementation target: patients with overall cognitive impairment among the participants, that is, those whose MoCA score is lower than 26. ② Implementation time: it will be implemented from the first week after joining the group, and then once a week for about 45 minutes, with a total of 10 times (the intervention period is 12 weeks). ③ Implementation form: Patients with networked computers at home can practice at home by themselves; Members of the patient intervention team without computer equipment go to the patient's home for home training once a week. ④ Training content: According to the cognitive results of patients' pre-intervention evaluation, the online cognitive training system will automatically recommend cognitive training modules suitable for patients (such as harvesting radish, anxious to return, indecision, careful calculation, etc.), and patients can train one by one according to the system recommendations and instructions. ⑤ Intervention and supervision: Computerized cognitive training: members of the research team log in to the background system every Friday to check the participants' completion of training, and remind the unfinished participants to finish actively in time. Knowledge and Skills Stimulation Training (Targeted Scheme 2) ① Implementation target: patients with overall cognitive impairment among the participants, that is, those whose MoCA score is lower than 26. ② Implementation time: it will be implemented from the sixth week after joining the group, and once a week thereafter (each cognitive training will end in 10-15min). ③ Implementation form: home follow-up, video or telephone supervision. ④ Implementation content: According to the principle of feedback method, let patients answer exercise-related precautions; On-site display of the use of inhalants; Answer the precautions of oxygen inhalation. Motivational intervention (targeting scheme 3) ① Implementation object: the participants with low activation degree, that is, those whose PAM tests are level 1 and level 2. ② Implementation time: from the second week to the eighth week after joining the group, 15-20 min each time, once a week, a total of 9 times (motivation interview); In the fifth week of joining the group, it will be implemented for more than 30 minutes each time, once in total (peer education). ③ Implementation content Set the timetable and theme of motivational interview: introduce the arrangement and rules of motivational interview to participants in the first interview; Subsequently, each interview was provided with corresponding health knowledge topics (exercise, respiratory muscle exercise, inhalant use, oxygen therapy, daily healthy life management, cognitive training or cognitive stimulation activities). Key points of motivational interview: Participants should rate their motivation and confidence in healthy behavior at each interview (1-10 points); Participants need to determine short-term goals to reveal the contradiction between these goals and their previous behaviors; At the end of the interview, summarize the main points, affirm the desirable behavior of the participants, ask questions, and ask the participants to try at least one strategy to improve self-efficacy and positive behavior change. Principles of motivational interview: open-ended questions and reflective answers; Resist corrective reflection; Understand and explore the patient's own motives; Empathy listening; Empowering patients, arousing hope and optimism Peer education: the research team members select 2-3 participants from patients with high activation, and share their experiences offline or online at Tencent conference. There is also a discussion session for patients to fully communicate and learn from each other's strengths. Implementation of patients with different subtypes of COPD: All participants in the intervention group implemented general scheme 1 and general scheme 2; Participants with low cognition/low activation simultaneously implement targeting scheme 1, targeting scheme 2 and targeting scheme 3; Participants with low cognition/high activation only implemented targeting scheme 1; Participants with normal cognition/low activation only implemented targeting scheme 2.

Intervention code：

组别：

对照组

样本量：

 36

Group：

Control group

Sample size：

干预措施：

对照组的参与者执行常规护理，即参与者接受研究团队成员的口头健康宣教，并为参与者提供医院统一为患者制定的教育手册。每两周电话随访患者一次。

干预措施代码：

Intervention：

Participants in the control group performed routine nursing, that is, participants received oral health education from the members of the research team, and provided participants with an education manual formulated by the hospital for patients. Follow-up patients by phone every two weeks.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 四川 

市(区县)：

 成都 

Country：

China

Province：

Sichuan

City：

Chengdu

单位(医院)：

 邛崃市医疗中心医院 

单位级别：

 三甲 

Institution
hospital：

Medical center hospital of Qionglai

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

自我管理能力

指标类型：

主要指标

Outcome：

Self management ability

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

患者生活质量

指标类型：

主要指标

Outcome：

Quality of life

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

吸入剂使用情况

指标类型：

主要指标

Outcome：

Usage of inhalants

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

慢阻肺相关知识

指标类型：

次要指标

Outcome：

Related knowledge of chronic obstructive pulmonary disease

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

整体认知功能

指标类型：

主要指标

Outcome：

Overall cognitive function

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

记忆功能

指标类型：

主要指标

Outcome：

Memory function

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

语言功能

指标类型：

主要指标

Outcome：

Language function

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

注意力

指标类型：

主要指标

Outcome：

Attention

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

执行功能

指标类型：

主要指标

Outcome：

Executive function

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

视觉空间能力

指标类型：

主要指标

Outcome：

Visual spatial ability

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

患者激活测量

指标类型：

主要指标

Outcome：

Patient activation measurement

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

焦虑、抑郁

指标类型：

次要指标

Outcome：

Anxiety and depression

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

6分钟步行距离

指标类型：

次要指标

Outcome：

6-minute walking distance

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肺功能指标测量

指标类型：

主要指标

Outcome：

Measurement of pulmonary function index

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

No have

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 40 岁 years
最大 Max age 80 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

对满足纳入及排除标准的患者进行计算机算计化法，将参与者分为对照组和干预组

Randomization Procedure (please state who generates the random number sequence and by what method)：

The patients who met the inclusion and exclusion criteria were calculated by computer, and the participants were divided into control group and intervention group.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

无

Blinding：

None

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

如需原始数据，在理由正当的情况可向数据收集者获取

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

If you need raw data, you can get it from the data collector when the reason is justified.

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

数据采集使用病历记录表，数据管理采用电子管理系统

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Data collection uses medical record form, and data management uses electronic management system.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2023-12-13 10:50:22